BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® GUIDE TEST STRIPS

    MDR report key: 16224722 · Received January 23, 2023

    Report

    Report Number
    3011393376-2023-00194
    Event Type
    Malfunction
    Date Received
    January 23, 2023
    Date of Event
    January 16, 2023
    Report Date
    March 10, 2023
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT OCCURRED OUTSIDE OF THE UNITED STATES WHILE THIS PRODUCT IS NOT SOLD IN THE UNITED STATES, IT IS LIKE OR SIMILAR TO A PRODUCT MARKETED IN THE UNITED STATES.

    Additional Manufacturer Narrative · 0

    SECTION H6: THE CUSTOMER RETURNED TWO STRIP VIALS FOR LOT 103529. THE INVESTIGATION DETERMINED THAT ONE VIAL HAD BEEN EXPOSED TO HUMIDITY, HEAT OR MOISTURE. THE OTHER VIAL PRODUCED ACCEPTABLE RESULTS AND MET SPECIFICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 339 MG/DL AND 152 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468574 ACCU-CHEK ® GUIDE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS NBW ROCHE DIABETES CARE, INC. 103529

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male